Can the European pharmaceutical sector rediscover its competitive edge?

Will Mario Draghi’s report be the wake-up call to rediscover the European pharmaceutical sector’s competitive edge?

Draghi’s report could be another warning missed as Europe risks hitting snooze on putting itself at the forefront of pharmaceutical innovation.

On Monday, Mario Draghi painted a stark picture of the future of Europe’s economy. As instructed by the European Commission, the former Italian Prime Minister and former President of the European Central Bank launched his report – ‘The future of European competitiveness.’

The message was clear: Europe is falling behind, losing ground to other countries like the United States and China, and in desperate need of innovation to rediscover its competitive edge. To avert this decline, an extra €800 billion a year in private and public investment will be needed.

This trend is all too familiar for Europe’s pharmaceutical sector. Sitting against the potential deprioritisation of health by the new European Commission, the question now is whether EU policymakers will take heed of Draghi’s warning for the sector and look to prioritise health and support for the pharmaceutical sector.

Sobering realities

The report set out the key barriers that prevent Europe from being the premier location for R&D and manufacturing of innovative medicines, particularly for the next wave of innovative treatments. These should not be a surprise to European policymakers, with many of these topics subject to ongoing debate as part of recent and ongoing legislative files.

• R&D Funding: EU public and private spending on research and innovation is well behind other markets, particularly the US.
• Delays in approving new medicines: Although this has been identified as a component of EU Pharmaceutical Legislation reform, the current regulatory framework remains too slow in approving new medicines.
• Reimbursement: Europe’s fragmented system across member states presents challenges for companies seeking reimbursement across the EU.

Responding to challenges

Although non-binding, the report sets out recommendations to tackle these challenges.

• Advancing progress made in digital health following the introduction of the European Health Data Space and embracing the role of AI across the lifecycle of medicines.
• Increasing EU funding with a focus on the development of world-class innovation hubs in life sciences for ATMPs.
• Joint procurement and increased cross-county partnership to streamline reimbursement for specific medicines.
• Creating a supportive environment for clinical trials through multi-country partnerships as well as reviewing clinical trial design and the use of real-world evidence.
• Reforming the regulatory landscape to ensure new medicines can reach patients quickly.

Draghi’s recommendations are ambitious and should compel the new Commission to take note. Although areas such as regulatory reform are being addressed through EU Pharmaceutical legislation reform, recommendations to develop ATMP innovation hubs and advance the role of AI will require investment and collaboration with industry.

The new Commission’s in-tray

As the new legislative term begins, reform of the EU Pharmaceutical Legislation will be an immediate priority. Efforts within the legislative file to futureproof the regulatory framework to speed up approvals are welcome but changes to reduce regulatory data protection could threaten Europe’s position.

As Draghi’s report makes clear, the sector needs bold ambition to remain competitive and as it stands it is unlikely EU Pharmaceutical Legislation reform alone can do this.

With European Commission President Ursula von der Leyen set to appoint her Commissioners next week, mission letters should prioritise health and support for the sector, setting an ambitious common goal that all stakeholders, including industry, can rally behind.

Perhaps a Strategy for European Life Sciences and a dedicated Officer for European Life Sciences could spur Europe into action, but time will tell if this is another wake-up call missed.